(161 days)
The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.
Ventlab Bacterial Filter BF100
This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Bacterial Filter BF 100". It states that the device is substantially equivalent to a predicate device, allowing it to be marketed. However, this document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.
Therefore, I cannot provide the requested information. The provided text is purely a regulatory approval letter and does not include the technical details of a study or performance evaluation.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 7 2003
Mr. Robert M. Kelly Director RA/QA Ventlab Corporation 2934 Highway 601 North Mocksville, NC 27028
Re: K030271
Trade/Device Name: Ventlab Bacterial Filter BF 100 Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: April 29, 2003 Received: April 30, 2003
Dear Mr. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration
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Page 2 -- Mr. Robert M. Kelly
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Kunn
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use:
510k Number : K030271
Applicant: Ventlab Corporation
Device Name: Ventlab Bacterial Filter BF100
The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
fHW.t.h.
Seneral Hospital.
510(k) Number: K030271
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).